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Diss Factsheets

Ecotoxicological information

Long-term toxicity to fish

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Reference
Endpoint:
fish early-life stage toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
Please see the cross-referenced supporting information to justify the waiving of chronic aquatic toxicity data.
Further discussion on the ecotoxicity of silicic acid producers can be found in the attached report “PFA, 2013x Analogue report Ecotoxicity of (poly)silicic acid producers_20130516”.
Reason / purpose for cross-reference:
data waiving: supporting information
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data waiving: supporting information
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data waiving: supporting information
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data waiving: supporting information
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data waiving: supporting information
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data waiving: supporting information
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data waiving: supporting information
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data waiving: supporting information

Description of key information

Key value for chemical safety assessment

Additional information

In accordance with Column 2 of REACH Annex IX, the long-term toxicity to fish (required in Section 9.1.5) does not need to be conducted.

On contact with water, silicon tetrachloride (CAS 10026-04-7) rapidly hydrolyses (half-life approximately 5 seconds at pH 7, 20-25°C) to monosilicic acid and hydrochloric acid.

Due to the rapid hydrolysis of the substance, the chemical safety assessment (CSA) is based on the silicon containing hydrolysis product monosilicic acid. The consideration of hydrochloric acid is discussed in IUCLID Section 6, CSR Section 7.0.  

No long-term toxicity to fish data are available with the registered substance or with monosilicic acid, on which the CSA is based. Testing for long-term toxicity to fish is not considered necessary because:  

Based on the short-term aquatic data set in which the organisms were exposed to the hydrolysis products, no effects were seen in any trophic level at the highest concentrations tested (the studies were carried out at or above loadings of 100 mg/l parent substance). As no effects were observed, there is no indication of higher sensitivity in fish compared to Daphnia and algae.  

The rapidly generated hydrolysis product, monosilicic acid, is inorganic, highly water-soluble and has low potential for bioaccumulation (refer to IUCLID Section 5.3 for further information).

Due to the substance being inorganic, PBT assessment does not apply and the substance cannot be classed as PBT or vPvB. On the basis of structure, monosilicic acid has a high affinity for water and low affinity for lipids and organic carbon. In addition, silicic acid and its condensation products are unlikely to diffuse across membranes or accumulate in fatty tissues, and are expected to be effectively eliminated in faeces and via the kidneys in urine (refer to IUCLID Section 7.1 for further information). There is therefore no evidence to suggest that this substance will accumulate in the body.   The substances in the silicic acid producers analogue group are silicon compounds with no carbon attached and which contain no structural features indicative of a specific mode of toxic action for ecotoxicity.  

Monosilicic acid exists only in dilute aqueous solutions and readily condenses at concentrations above approximately 100-150 mg/l as SiO2 to give a dynamic equilibrium between monomer, oligomers and insoluble polysilicic acid.   (Poly)silicic acid is a naturally occurring substance, ubiquitous to the natural environment, which is not harmful to aquatic organisms at relevant environmental concentrations.

(Poly)silicic acid is the major bioavailable form of silicon for aquatic organisms and plays an important role in the biogeochemical cycle of silicon (Si). Most living organisms contain at least trace quantities of silicon. For some species Si is an essential element that is actively taken up. For example, diatoms, radiolarians, flagellates, sponges and gastropods all have silicate skeletal structures (OECD SIDS 2004a; PFA 2013x). (Poly)silicic acid has been shown to be beneficial in protection against mildew formation in wheat and to be non-phytotoxic in non-standard studies (Côte-Beaulieu et al. 2009).   Further discussion on the ecotoxicity of silicic acid producers can be found in the attached report “PFA, 2013x Analogue report Ecotoxicity of (poly)silicic acid producers_20130516”.  

As inorganic substances, soluble silicates are not amenable to photo- or biodegradation (OECD SIDS 2004a), therefore will not give rise to toxic degradation products. The bioavailable forms of silica are dissolved silica [Si(OH)4] almost all of which is of natural origin (OECD SIDS 2004a). Anthropogenic sources of silicic acid will rapidly depolymerise in the aquatic environment to give molecular species indistinguishable from natural dissolved silica (OECD SIDS 2004c). The potential releases of inorganic silicon resulting from use of the registered substance are negligible compared to the natural flux of silica in the environment (refer to IUCLID Section 5 endpoint summary for further information).   Because silicic acid occurs naturally in the environment and organisms are naturally adapted to utilise silica, and because monosilicic acid, oligomeric and polysilicic acids from anthropogenic sources will enter the natural biogeochemical cycles and will be indistinguishable from naturally occurring silica, the registered substance, which rapidly hydrolyses to silicic acid, is not expected to be harmful to organisms present in the environment. There are no chronic aquatic toxicity data for silicic acid, but due to the known inherent physico-chemical properties, absence of acute toxic effects as well as the ubiquitous presence of silicic acid in the environment, there is no evidence of harmful long-term effects arising from exposure to silicic acid and its precipitation products.  

Overall, it is concluded that no hazard is identified and therefore further in vivo testing is not considered necessary or justified on ethical grounds.    

Details on how the substance is evaluated for risk can be found in IUCLID Section 6.0, and Chapters 7, 9 and 10 of the Chemical Safety Report.